S3621-118

Introduced

To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes.

118th Congress Introduced Jan 18, 2024

Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.

Summary

What This Bill Does

This bill, To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Technology, Transportation.

Who Benefits and How

health care providers and patients may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.

Who Bears the Burden and How

federal implementing agencies, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.

Key Provisions

  • Section HCD71D2310C7745F8B41133393E44E2EA: 1. Short title This Act may be cited as the Medical Device Nonvisual Accessibility Act of 2024.
  • Section H22A9AE77A1874ADB9F3E751C8F778F28: 2. Findings Congress finds the following: Rapid advances in digital technology have led to increasingly complex user interfaces for everyday products, such as...
  • Section H6AC154ACDCC04972B0E4C7BE03E5EF06: 3. Nonvisual accessibility standards for certain devices Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by adding at the...
  • Section HC2365BCD772444C8B590CA0FF543C4D0: 515D. Nonvisual accessibility standards for certain devices The nonvisual accessibility standard specified in this section is, with respect to a user interface...

Evidence Chain:

This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.

At a Glance

What This Bill Does

This bill, To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.

Key Policy Areas

Healthcare, Technology, Transportation

Primary Purpose

This bill, To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.

Policy Domains

Healthcare Technology Transportation

Whole bill

Identified Gains
  • health care providers and patients
Model: codex-gpt-5 | Version: bill_summary_v2 | Source: is
health care providers and patients: ,
Identified Costs
  • federal implementing agencies
  • health care providers and patients
Model: codex-gpt-5 | Version: bill_summary_v2 | Source: is
federal implementing agencies: ,
health care providers and patients: ,

Legislative Progress

Introduced
Introduced Committee Passed
Jan 18, 2024

Ms. Hassan (for herself and Mr. Braun) introduced the following …

Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →

Bill Structure & Actor Mappings

Who is "The Secretary" in each section?

Domains
Healthcare Technology Transportation
Actor Mappings
"the_secretary"
→ The Secretary identified in the operative section

Key Definitions

Terms defined in this bill

1 term
"covered device" §H6AC154ACDCC04972B0E4C7BE03E5EF06

a device that— is classified under section 513 into class II or III

We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.

Learn more about our methodology